MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R2.0, TI, LEFT GAMMA3® Ø11X400MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 33250400S

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 09/05/2016

Event Type  Injury  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event Description

After taking a x-ray it was noticed that the nail broke.

Manufacturer Narrative

The evaluation revealed the broken nail to be the primary product.No deviations were found during review of the manufacturing and inspection documents (dhr).The nail was documented as faultless prior to distribution.The evaluation revealed that the nail broke most likely in a fatigue fracture after a period of approx.3 months of implantation.According to found damages the fatigue fracture had its origination in the anterior web at lateral.In this area significant material damage had weekend the web caused by misaligned drilling with the step drill; which presents an unintentional use error.Significant material deformation incl.Material seizing (bearing points) of the medial edge of the proximal drill hole was most likely caused by increased axial loading during the implantation period; which is considered as patient behaviour related.According to the operation reports and compared with provided x-rays there was no suspicious situation found in regards from technical point of view.A nail will be subject of a fatigue fracture if the stresses on the implant are too high or not considerably reduced during the period of implantation.The affected implant is designed to withstand the normal loads during the implantation period, i.E.The implant must neither be exposed to peak loads nor to continuous stresses.Another prerequisite for a successful supply is undisturbed, normal bone healing.This state must be achieved within a medically recognized period (confirmed by scientific analysis about 6 months) in such way, that the bone strength allows significantly increasing discharge of the time-fixed implant material.In case that such a situation does not occur, exceeding of the fatigue strength is to be expected and thus quite predictable complications.In this case the nail broke in an area where the material had been weakened significantly by intra-operative misaligned drilling which was considered as user related.Referring to additional material damage in and around the bearing points inside the proximal drill hole it could not be excluded that increased axial load during the implantation period.This would be considered as patient related.However, the operation report of the initial surgery did not contain instructions regarding weight bearing.Based on the above the nail breakage was not linked to a deficiency of the device, but was mainly user related, most likely contributed by the patient¿s load application.Review of complaint history, capa databases and risk analysis did not identify any conspicuity.The review of the risk assessment for the failure mode indicated the issue was addressed adequately.There are no actions in place related to the reported event for the subject product.No non-conformity was identified.The event was not linked to a deficiency of the device.

Event Description

After taking a x-ray it was noticed that the nail broke.

• Brand Name: LONG NAIL KIT R2.0, TI, LEFT GAMMA3® Ø11X400MM X 125°
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6149746
• MDR Text Key: 61592539
• Report Number: 0009610622-2016-00606
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: K034002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: 33250400S
• Device Lot Number: K0D0A57
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Weight: 80